Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy (AML)

August 17, 2019 updated by: Pfizer

GEMTUZUMAB OZOGAMICIN (MYLOTARG (REGISTERED)) EXPANDED ACCESS PROTOCOL FOR TREATMENT OF PATIENTS IN THE UNITED STATES WITH RELAPSED/REFRACTORY ACUTE MYELOGENOUS LEUKEMIA WHO MAY BENEFIT FROM TREATMENT AND HAVE NO ACCESS TO OTHER COMPARABLE/ALTERNATIVE THERAPY

An expanded access/compassionate use protocol that allows access to Mylotarg for relapsed/refractory AML CD33 positive patients in the USA.

Contact: B1761026@iconplc.com

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

Contact:

B1761026@iconplc.com

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham/Children's of Alabama
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
      • Anchorage, Alaska, United States, 99508
        • Providence Cancer Center
      • Anchorage, Alaska, United States, 99508-2980
        • Alaska Oncology & Hematology, LLC
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Banner Pediatric Specialists Hematology/Oncology Clinic
      • Mesa, Arizona, United States, 85202
        • Cardon Children's Medical Center.
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital of Los Angeles - University of Southern California School of Medicine
      • Oakland, California, United States, 94611
        • Kaiser Permanente - Oakland
      • Oakland, California, United States, 94611
        • Kaiser Permanente - Oakland Medical Center
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
      • Roseville, California, United States, 95661
        • Kaiser Permanente - Roseville
      • San Diego, California, United States, 92123
        • UCSD/ Rady Children's Hospital
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente - Santa Clara
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
      • New Haven, Connecticut, United States, 06510
        • C/O Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven
      • New Haven, Connecticut, United States, 06510
        • Smilow Cancer Hospital at Yale-New Haven
      • New Haven, Connecticut, United States, 06510
        • Yale New-Haven Hospital & Smilow Cancer Center
      • Trumbull, Connecticut, United States, 06611
        • Yale Medical Group
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Nemours - A.I. duPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital
      • Hollywood, Florida, United States, 33021
        • Joe DiMaggio Children's Hospital
      • Hollywood, Florida, United States, 33021
        • JDCH pediatric Oncology and Hematology
      • Jacksonville, Florida, United States, 32207-8426
        • Nemours Children's Clinic
      • Jacksonville, Florida, United States, 32207
        • Baptist Medical Center/Wolfson Children's Hospital
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
      • Orlando, Florida, United States, 32827
        • Nemours Children's Hospital
      • Orlando, Florida, United States, 32804
        • Cancer Institute Of Florida
      • Orlando, Florida, United States, 32804
        • Blood and Marrow Transplant Center
      • Pembroke Pines, Florida, United States, 33021
        • Memorial Cancer Institute at Memorial Hospital West
      • Pembroke Pines, Florida, United States, 33021
        • Memorial Hospital West
      • Saint Petersburg, Florida, United States, 33701
        • Johns Hopkins All Children's Hospital
      • Saint Petersburg, Florida, United States, 33701
        • Johns Hopkins All Children's Hospital IDS Pharmacy
      • Saint Petersburg, Florida, United States, 33701
        • Johns Hopkins All Children's Outpatient Care Pediatric Hematology/Oncology Department
      • Tampa, Florida, United States, 33612
        • H.Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Children's Healthcare of Atlanta at Scottish Rite
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta at Egleston
      • Atlanta, Georgia, United States, 30342-4790
        • The Blood & Marrow Transplant Group Of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medical Center
      • Chicago, Illinois, United States, 60637
        • Investigational Drugs Service Pharmacy, Attn. Judy Pi, PharmD, Ami Patel, PharmD
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Maywood, Illinois, United States, 60153
        • Cardinal Bernardin Cancer Center/Loyola University Medical Center
      • Maywood, Illinois, United States, 60153
        • Loyola University Chicago, performing research at Loyola University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IU Health Pharmacy
      • Indianapolis, Indiana, United States, 46237
        • Indiana Blood and Marrow Transplantation
      • Indianapolis, Indiana, United States, 46202-5225
        • Indiana University Riley Hospital for Children
      • Indianapolis, Indiana, United States, 46237
        • Indiana Blood and Marrow Transplantation - Administrative Offices
      • Indianapolis, Indiana, United States, 46237
        • St.Francis Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University Of Kansas Hospital
      • Westwood, Kansas, United States, 66205
        • University of Kansas Cancer Center
      • Westwood, Kansas, United States, 66205
        • The University of Kansas Cancer Center and Medical Pavilion
      • Westwood, Kansas, United States, 66205
        • The University of Kansas Cancer Center and Medical Pavillion
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • UK Healthcare Markey Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins University IDS Pharmacy
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • The West Clinic, P.C. dba West Cancer Center
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Siteman Cancer Center - West County
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63110
        • Barnes-jewish Hospital
      • Saint Louis, Missouri, United States, 63129
        • Siteman Cancer Center - South County
      • Saint Louis, Missouri, United States, 63110
        • Washington University Infusion Center Pharmacy
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine, Siteman Cancer Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson University Hospital
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • East Setauket, New York, United States, 11733
        • North Shore Hematology Oncology Associates, P.C.
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10021
        • Weill Cornell Medical College - New York-Presbyterian Hospital
      • New York, New York, United States, 10065
        • Weill Cornell Medical College - New York-Presbyterian Hospital
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Rochester, New York, United States, 14642
        • University of Rochester Cancer Center Pharmacy
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Vidant Medical Center
      • Greenville, North Carolina, United States, 27834
        • Brody School of Medicine at ECU
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland Rainbow Babies & Children's Hospital
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Hershey, Pennsylvania, United States, 17033
        • Milton Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19134
        • St. Christopher's Hospital for Children
      • Philadelphia, Pennsylvania, United States, 19107-4215
        • Thomas Jefferson University (Tju) - Jefferson University Physicians (Jup)
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University, Investigative Drug Service
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office (Clinical)
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office (Regulatory)
      • Pittsburgh, Pennsylvania, United States, 15224
        • Allegheny Health Network, Cancer Institute, West Penn Hospital
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The West Clinic, P.C. dba West Cancer Center
      • Knoxville, Tennessee, United States, 37916
        • East Tennessee Children's Hospital
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital
      • Memphis, Tennessee, United States, 38120
        • The West Clinic, P.C. dba West Cancer Center
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
      • Nashville, Tennessee, United States, 37232
        • Monroe Carell Jr. Children's Hospital at Vanderbilt
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, United States, 37203
        • The Children's Hospital at TriStar Centennial
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology - Nashville
      • Nashville, Tennessee, United States, 37203
        • TriStar Centennial Medical center
      • Nashville, Tennessee, United States, 34203
        • Sarah Cannon Research Institute
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Center for Blood Cancer
      • Nashville, Tennessee, United States, 37203
        • TriStar Centennial Medical Center/Sarah Cannon Cener for Blood Cancer
      • Nashville, Tennessee, United States, 37203
        • TriStar Medical Group Children's Specialist
      • Nashville, Tennessee, United States, 37212
        • VA Tennessee Valley Healthcare System - Nashville Campus
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center - The Vanderbilt Clinic
    • Texas
      • Austin, Texas, United States, 78723
        • Dell Children's Medical Center of Central Texas
      • Austin, Texas, United States, 78723
        • Dell Children's Medical Center
      • Austin, Texas, United States, 78723
        • Children's Blood and Cancer Center
      • El Paso, Texas, United States, 79905
        • El Paso Children's Hospital
      • El Paso, Texas, United States, 79905
        • Texas Tech University Health Sciences Center
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Medical Center
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Hematology/Oncology Center
      • Grapevine, Texas, United States, 76051
        • Cook Children's Hematology/Oncology Center - Grapevine
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital Attn: Investigational Pharmacy Services
      • Houston, Texas, United States, 77584
        • Houston Methodist Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's Hospital
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute-University of Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • UVA Health System
      • Charlottesville, Virginia, United States, 22903
        • Emily Couric Clinical Cancer Center
      • Charlottesville, Virginia, United States, 22903
        • Cancer Center IDS Pharmacy Attn: Lauren Benusa, Pharm D.
      • Hampton, Virginia, United States, 23666
        • Virginia Oncology Associates
      • Norfolk, Virginia, United States, 23507
        • Children's Hospital of the King's Daughters
      • Virginia Beach, Virginia, United States, 23456
        • Virginia Oncology Associates
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center First Hill, IDS Pharmacy
      • Seattle, Washington, United States, 98105
        • Seattle Children's IDS Pharmacy - Attn. Laura Winter
      • Seattle, Washington, United States, 98122
        • Lisa Nakatsu, RPh
    • Wisconsin
      • Appleton, Wisconsin, United States, 59413
        • Fox Valley Hematology & Oncology, SC
      • Green Bay, Wisconsin, United States, 54311
        • Aurora BayCare Medical Center
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College Of Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin
      • Oshkosh, Wisconsin, United States, 59404
        • Fox Valley Hematology & Oncology, SC
      • Wauwatosa, Wisconsin, United States, 53226
        • Aurora Health Care, Aurora Cancer Care
      • West Allis, Wisconsin, United States, 53227
        • Aurora Health Care, Aurora Cancer Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of relapsed/refractory AML (defined as >=5% marrow blasts by morphology), including MDS, with persisting rising blasts and no other comparable or satisfactory alternative therapy available. If bone marrow has <5% blasts by morphology but the patient has evidence of relapse with extra-medullary disease progression. In select cases presenting with conversion of MRD from negative to positive, treatment with GO may be allowed where no alternative treatments are feasible.

OR

  • Confirmed diagnosis of relapsed or refractory APL with persisting or rising leukemic burden (either by morphology, cytogenetic analysis or by molecular techniques), and no other comparable or satisfactory alternative therapy available.

  • Documentation that malignant cells express CD33

    4) Age >=3 months

    5) Adequate non-hematologic organ function

Exclusion Criteria:

  • Untreated AML and MDS or AML and MDS in complete remission.
  • Patients with a known history of VOD/SOS.
  • Patients with a known hypersensitivity to Mylotarg or its parts: hP67.6 antibody, calicheamicin derivatives or other ingredients.
  • Participation in other studies involving investigational drug(s) (Phases 1-4) during study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 4, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 9, 2014

Study Record Updates

Last Update Posted (Actual)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 17, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1761026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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